New Publication | CISCER® Methylation Testing Provides a More Precise Cervical Cancer Screening Option for Middle-Aged and Elderly Women
Recently, a large-sample clinical study published in the internationally authoritative journal International Journal of Cancer demonstrated that PAX1/JAM3 gene methylation testing (trade name: CISCER®) achieves sensitivity and specificity exceeding 90% for high-grade cervical lesions (CIN2+ / CIN3+) in postmenopausal (≥50 years) women, significantly outperforming traditional screening methods. It can also effectively detect cases missed by hrHPV-negative or normal cytology (adenocarcinoma and high-grade lesions), providing a more precise non-invasive molecular testing tool for cervical cancer screening in middle-aged and elderly women.
— Latest study shows methylation testing effectively identifies high-grade lesions commonly missed in women over 50 —
1. Study Background and Methods
Due to physiological changes such as cervical atrophy and inward migration of the squamocolumnar junction in postmenopausal women, the sensitivity of traditional cytology and colposcopy decreases, leading to higher missed diagnosis risk. The research team enrolled 428 subjects who underwent colposcopic evaluation between 2023 and 2025, of whom 216 were postmenopausal women aged ≥50 years as the primary analysis population. The study used the NMPA-approved CISCER® reagent for testing and systematically compared its diagnostic performance with liquid-based cytology (LBC) and hrHPV testing.
2. Key Study Results
Detection performance for CIN2+ in the ≥50-year age group: CISCER® achieved a sensitivity of 93.2% for CIN2+ and 97.2% for CIN3+, with specificity maintained above 93% and AUC reaching 0.934. In comparison, LBC sensitivity was only 75.0% with specificity of 52.3%; hrHPV testing, while highly sensitive (95.5%), had specificity of only 20.3%, resulting in persistently high false-positive rates.
3. Outstanding Clinical Value, Filling Screening Blind Spots
Two cases of cervical adenocarcinoma that were hrHPV-negative with normal cytology were missed by traditional methods but were both accurately identified by CISCER®. Additionally, the test effectively detected high-grade lesions with non-16/18 type hrHPV infection that were missed by LBC, demonstrating broad applicability in the context of diverse HPV infections.
4. As a Triage Tool, Optimizing Diagnostic Pathways
Using CISCER® for triage after initial cytology or HPV screening can significantly reduce false-positive rates (by over 90% in some scenarios), decrease unnecessary colposcopy referrals and biopsies, and reduce medical burden while maintaining detection rates.
5. Conclusion
The CISCER® (PAX1/JAM3) methylation test provides a more precise and reliable molecular tool for cervical cancer screening in middle-aged and elderly women, particularly suitable for populations prone to missed diagnosis by traditional methods, and is expected to serve as an important basis for future screening guideline updates.
Article Information:
Peng H, Li J, Zhou Q, et al. Enhanced diagnostic accuracy of high-grade cervical intraepithelial neoplasia in postmenopausal women through PAX1/JAM3 methylation analysis. Int J Cancer. doi:10.1002/ijc.70245
Beijing Origin CISPOLY Biotechnology Co., Ltd. is a technology enterprise driven by innovative science and focused on health. CISPOLY is a pioneer in the field of early diagnosis of gynecologic tumors. With proprietary technology and patent-protected biomarkers at its core, the company has developed early diagnostic products for cervical cancer, endometrial cancer, ovarian cancer, and other gynecologic tumors, filling a void in this field.
As women pay increasing attention to their own health, the women's health market holds great promise. Beyond its gynecologic tumor early screening and diagnosis product line, CISPOLY will continue to build additional women's health-related product pipelines, striving to become a technology-innovation-driven leader in the women's health market.